FDA Urges Moms-To-Be Who Must Take Prescription Drugs to Join Pregnancy Registry

About 6 million women become pregnant in the US every year. The average mom-to-be uses three to five prescription drugs during her pregnancy. While the potential impact of prescription medication upon an unborn child is always a concern, many expecting women must continue to take necessary medications for conditions such as diabetes, cancer, migraines, asthma or HIV/AIDS throughout their pregnancy. Other moms unwittingly expose their developing fetuses to prescription drugs before they realize they are pregnant - about half of pregnancies in the US are unplanned.

The issue is complicated by the lack of information on the effects of many drugs on a developing fetus or breastfeeding child. In an attempt to add to the information base, the FDA is encouraging pregnant and breastfeeding women to participate in pregnancy registration studies. These studies collect and maintain data on the effects of prescription medications on pregnant and nursing women and their babies, in an effort to identify and manage risks. “The FDA’s goal is to have data about the use of medicines during pregnancy for all medicines that are used by women of childbearing potential,” says Dr. Karen Feibus, an expert in maternal health. That information will allow pregnant and nursing women to make informed choices about using prescription drugs.

The FDA reviews applications for new prescription drugs and decides if the manufacturer should be required to set up a pregnancy regis­try if they are approved. On occasion, drug manufacturers or health professionals set up registries proactively. The registries collect information on treatments for a variety of common illnesses and conditions where leaving the medical condition untreated during pregnancy can pose more risk to the mother and unborn child than taking the medication – for example, women with epilepsy should continue to take seizure medications rather than risk an epileptic seizure. Women participating in the registries don't take any experimental medications, or any prescription drugs they would not normally be taking.

Women taking prescription drugs while pregnant or breastfeeding can contact the drug manufacturer, their doctor or a pharmacist to participate in a registry. Typically, they provide the registry with demographic information (age, weight, medical condition, geographical location, etc.), information on the type of prescription medication they are taking, and any effects on themselves or their children. 

Boston's Massachusetts General is currently documenting the use of over 30 prescription medications in pregnant and nursing women. The Epilepsy Foundation is urging women to enroll in another large registry - the North American Antiepileptic Drug Pregnancy Registry, which is studying the effects of common antiseizure drugs such as Lamictal (lamotrigine) and Lamictal XR. One of the known lamictal side effects that may affect pregnant women is the lowering of the body's levels of folic acid.  As folic acid is known to decrease the risks of birth defects, doctors advise that pregnant women taking the seizure medication also take a folic acid supplement.